NDC Package 0378-2071-05 Letrozole

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0378-2071-05

Package Description:

500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Product Code:

0378-2071

Proprietary Name:

Letrozole

Usage Information:

This medication is used to treat certain types of breast cancer (such as hormone-receptor-positive breast cancer) in women after menopause. Letrozole is also used to help prevent the cancer from returning. Some breast cancers are made to grow faster by a natural hormone called estrogen. Letrozole decreases the amount of estrogen the body makes and helps to slow or reverse the growth of these breast cancers.

11-Digit NDC Billing Format:

00378207105

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

500 EA

Labeler Name:

Mylan Pharmaceuticals Inc.

Sample Package:

FDA Application Number:

ANDA078190

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-22-2011

End Marketing Date:

11-30-2013

Listing Expiration Date:

11-30-2013

Exclude Flag:

Code Structure:

0378 - Mylan Pharmaceuticals Inc.
- 0378-2071 - Letrozole
  - 0378-2071-05 - 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0378-2071-05?

The NDC Packaged Code 0378-2071-05 is assigned to a package of 500 tablet, film coated in 1 bottle, plastic of Letrozole, labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is and is administered via form.

Is NDC 0378-2071 included in the NDC Directory?

The product was first marketed by Mylan Pharmaceuticals Inc. on April 22, 2011 and its listing in the NDC Directory is set to expire on November 30, 2013 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0378-2071-05?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 500.

What is the 11-digit format for NDC 0378-2071-05?

The 11-digit format is 00378207105. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0378-2071-05	5-4-2	00378-2071-05

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